Good Laboratory Practice Standards

Applications for Field and Laboratory Studies

Edited by Willa Y. Garner, Maureen S. Barge, and James P. Ussary

Description

Written by experienced quality assurance (QA) professionals and field laboratory researchers. Provides concrete ideas for establishing a compliance program and refining the compliance process. Outlines approaches that have resulted in successful compliance and describes methods of avoiding some of the common mistakes. Appendices contain the entire GLP Enforcement Response Policy, a question-and-answer section, examples of forms for submitting data to the EPA, and the EPA's penalty policy.

Good Laboratory Practice Standards

Applications for Field and Laboratory Studies

Edited by Willa Y. Garner, Maureen S. Barge, and James P. Ussary

Table of Contents

Responding to Regulatory Changes in Agrochemical ResearchManagement Commitment to the Good Laboratory Practices ProcessPreparing Standard Operating Procedures for Field StudiesPreparing Standard Operating Procedures for the LaboratoryDesigning Protocols for Field StudiesPractical Protocols for the LaboratoryTest Substance and Specimen Chain of Custody in Field StudiesPractical Applications for Chain of Custody Within an Analytical LaboratoryTest Substance and Analytical Reference Standard Characterization and AccountabilityReporting Study ResultsThe Quality Assurance Unit: The Master Schedule and the ArchivesFacility Inspection Conduct: Quality Assurance Perspective for Field StudiesAnalytical Phase
Inspection of Residue Chemistry and Environmental StudiesData Audits for Field StudiesLaboratory Data AuditingWorking Models of Computer System Validation and VerificationValidation of Laboratory Computer SoftwareProduct Chemistry from the Formulation PerspectiveCompliance for Routine and Nonroutine Field StudiesNonbiased Field SamplingProcessing StudiesLivestock StudiesSpecialized Field Testing: Worker ProtectionMesocosm Studies and Other Aquatic Field Studies with PesticidesTerrestrial Field StudiesProblems with Ecotoxicological Field StudiesAgrochemical Groundwater StudiesRunoff StudiesAuditing Field Studies: Government PerspectiveIs the Federal Insecticide, Fungicide, and Rodenticide
Act Good Laboratory Practices Program at a Crossroads?Good Laboratory Practice Standards Policies and InterpretationsEconomic Impact of Regulations on Field Contractors and an Agrochemical CompanyHarmonization and Prospects for the Future